Sunday, November 18, 2012
Rxisky Business - The Importance of Being Earnest
I've always wanted to use film titles as a title for a post, the above, Rxisky Business - The Importance of Being Earnest, kills two birds with one stone and, if I say so myself, is pleasing on the eye.
So, what am I trying to say here and why have I misspelled the word 'Risky'?
Well, this post is about the importance of filing adverse reactions to prescription drugs on RXISK.ORG, a reporting system with a difference in as much that they actually follow through the reports you send to them.
So, why report to RXISK opposed to the FDA, MHRA, TGA or Medsafe?
In a nutshell, RXISK seeks to gather adverse reactions and do something about them. The FDA et al just sit on reports and, when questioned about the high volumes of reactions to certain drugs, blame everything but the drug. Hardly surprising as they are run by ex-pharmaceutical employees whose vested interest is not in the patient but more in the stocks and shares they hold with their former employers.
The RXISK approach is different. Once you file an adverse reaction to any prescription medication it will be looked at by a team of people who will then send you back a report, not only to say 'thank you for filing a report' but also to follow up on the information you provide.
More often than not families tend to think that a drug prescribed by a doctor would not be prescribed if it posed a risk to the patient. I can tell you now that this is not the case. What the general public probably don't know is that we are all part of an on-going clinical trial, a trial that has four phases from the conception of a drug right through to the licensing.
When a clinical trial is undertaken those involved are supposed to be vigilant on any type of reaction, be it a headache, nausea or suicidal feelings. Headaches and nausea are well noted, anything that is minor usually is. However, what pharmaceutical companies tend to do is remove any subjects from the trials who respond poorly to their drugs. This skews the safety and efficacy results, which are never seen by regulators who grant licence for the drugs to be sold and marketed to the general public.
Post Marketing Surveillance
PMS is the stage of the trial where the public need to get involved. The ignorance of the regulators in this stage is staggering. One only has to look at drugs that were initially granted a licence by the regulators only to be withdrawn later because of the Post Marketing Surveillance (reports sent in by doctor's and the public) For the blockbuster drugs this takes years for the regulator to act. In truth, pharma get what they can out of a drug [financially] before agreeing to pull it from the shelves. It's called collateral damage.
It's a complete waste of time writing to the manufacturers of these drugs, they see a few deaths here and there as something that can easily be buried and played down by using the original illness as the cause of death.
This is where Rxisk is unique. It gives feedback and will help the patient understand the reasons why they could be suffering from x,y or z. Armed with a report from Rxisk the patient could then actually confront their prescribing physician to let them know that they, as patients, are having a reaction to the medication. The doctor's, in the main, go on information that the drug companies provide them and what the regulators provide them which is, in essence, identical.
I've chastised the British drug regulator many times. Their reporting system (Yellow Card) is outdated and the follow-up is abysmal. An impartial regulator has been needed for some time now. I mean, who would want Joe Bloggs from the MHRA telling them that the drug did not cause suicidal thoughts, it was the illness, when Joe Bloggs worked for the very same company who manufactured the drug you are reporting. FDA are the same.
Rxisk is an import tool in bringing about change. Pharma or the regulators, whom are Pharma by proxy, won't like it - why would they as it is basically doing the job that they are supposed to do - protecting the public.
As the tagline says on Rxisk, "You've been handed a megaphone to help change drug safety. Make your voice heard!"
Always remember the following quote folks, read it to yourself over and over if you have to. Change will only happen if you are involved.
I wondered why somebody didn't do something. Then I realized, I am somebody.
Rxisk can be found here